Why it's used

Valbenazine Tosylate is used to treat adults with brain disorder involving involuntary movements of the face and jaw (tardive dyskinesia). It is a prescription medicine. This medicine works by altering the activity of various natural substances present in the brain.
Vesicular Monoamine Transporter 2 Inhibitors
Valbenazine belongs to a class of medicines called Vesicular Monoamine Transporter 2 Inhibitors. Vesicular Monoamine Transporter 2 Inhibitors.

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How to use

Read the directions on the product label, patient guide, or medicine guide provided by the medicine company or your pharmacist before starting to use Valbenazine Tosylate. If you have any questions related to this medicine, ask your doctor or pharmacist. Eat this medicine as recommended by your doctor.
Valbenazine Tosylate is eaten with or without food.

Typical Dosage

The typical dose of Valbenazine is 80 mg once daily. Valbenazine is commonly used at the same time every day.

Talk to Your Doctor

Talk to your doctor if your condition does not improve or worsens. If you have issues with the health of your liver, It is advised to minimize the dose for patients having severe liver damage (indicating when Child-Pugh score was between 7 to 15). Such patients show more absorption to Valbenazine than patients with the normal functioning of the liver. You should consult with your doctor before stopping the use of Valbenazine.
Your doctor may recommend a lower initial dose of this medicine to see the impact of this medicine on the body. Please follow your doctor's directions.

Use in Children

The safety and effectiveness of using Valbenazine Tosylate in children has not been established. Effectiveness and safety of Valbenazine have not been studied in children.

Storage

You should store Valbenazine Tosylate 20°C to 25°C (68°F to 77°F), and away from moisture. Store the medicine away from the reach of children and pets.
Medicines may be prescribed for uses other than those listed in the medicine guide. Do not use Valbenazine Tosylate for conditions for which it was not prescribed. Do not give Valbenazine Tosylate to other people who might have the same conditions or symptoms that you have. Self-medication may harm them.

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How to take Valbenazine

The dose and frequency of using Valbenazine will depend on the following factors:
  • the health of the patient's kidneys
  • medicines recommended by the doctor
  • any other medicines being used
  • herbal supplements being used

Valbenazine Dosage

Dosage for uncontrolled movement of the body parts

Adult
  • Recommended: 80 mg once daily
  • Initial: 40 mg once daily

Forms

Capsule
Strength: 40 mg and 80 mg

Missed Dose

The missed dose should be taken as soon as you remember it. However, if it is almost time for your next dose, the missed dose should be skipped, and the regular dosing schedule should be continued. A double dose should not be taken to make up for a missed dose.

Overdose

What to do if you overdose on Valbenazine?
There is no specific antidote available for Valbenazine. In case of overdose supportive care and complete monitoring of patient should be done. The use of multiple drugs should be avoided.
Symptoms of an overdose of Valbenazine
If you use too much of this medicine, it could lead to dangerous levels of the medicine in your body. In such cases, symptoms of an overdose may include:
If you think you have overdosed on Valbenazine Tosylate, call a poison control center immediately. You can look up the poison control center information from the Poison Center Finder at TabletWise.com.

Precautions while using Valbenazine

Before you use Valbenazine, tell your doctor of your medical and health history including the following:
  • allergic reactions
  • heart attack
  • heart disease
  • irregular heartbeat
  • liver problems
Valbenazine causes liver problems which may include an increase in bilirubin and alkaline phosphatase level and cause reduction or stoppage of bile flow. It may cause heart problems, e.g. heart rhythm disorder.
Before you use Valbenazine Tosylate, discuss with your doctor if you are allergic to it or its ingredients. Your doctor may prescribe an alternative medicine and update your medical records to record this information.
The use of this medicine may change the alkaline phosphatase level. There is an increase in the level of alkaline phosphatase which is dose-dependent.
The use of Valbenazine Tosylate may change the prolactin level. There is an increase in the level of prolactin which is dose-dependent.
The use of this medicine may change blood sugar level. There is an increase in blood sugar level.
The use of Valbenazine Tosylate may change the bilirubin level. There is an increase in the level of bilirubin which is dose-dependent.

Dizziness

Valbenazine Tosylate can make you feel sleepy. Be careful when using any machinery, driving a vehicle, or doing any other activity that needs you to be fully alert. The consumption of alcohol with Valbenazine Tosylate can worsen the sleepiness.

Use in Pregnancy

The use of Valbenazine is known to be safe in women who are pregnant or planning to become pregnant. Valbenazine shows a possible risk to the fetus. So it is not recommended during pregnancy.

Use while Breastfeeding

The use of Valbenazine Tosylate is known to be safe for use in women who are breastfeeding. It is advised to avoid breastfeeding during Valbenazine treatment and also after completion of 5 days of Valbenazine treatment.

Use while Conceiving

Valbenazine is known to be safe for use in women who are trying to conceive a baby. Valbenazine may cause harm to the fetus. So the patient should inform the doctor before taking Valbenazine if they are planning to become pregnant.

What precautions should be taken during Pregnancy and Nursing, and administering Valbenazine to Children or the Older Adults?

Pregnant Women

Contraindicated or Not Recommended
Warning: Valbenazine shows possible risk to an unborn baby. So it is not recommended to use in pregnancy.

Breastfeeding

Precaution
Warning: It is advised to stop breastfeeding during Valbenazine treatment and also after completion of 5 days of Valbenazine treatment.

Younger Adults Population

Contraindicated or Not Recommended
Warning: Effectiveness and safety of Valbenazine have not been studied in children.

Older Adults Population

Possibly safe
Warning: There is no need for dose adjustment of Valbenazine in elderly patients. The placebo-controlled based studies of Valbenazine showed no difference in the results of safety and effectiveness in younger patients and patients older than 65 years.

Valbenazine Side-effects

The following side-effects may commonly occur when using Valbenazine Tosylate. If any of these side-effects worsen or last for a long time, you should consult with your doctor:
Rarely, the use of Valbenazine Tosylate may cause the following side-effects:
  • a decrease in bile flow
  • increase in prolactin
The following severe side-effects may also occur when using Valbenazine Tosylate:
  • General disorders
    Symptoms: increased weight
  • Nervous system disorders
    Symptoms: the flow of saliva outside the mouth, uncontrolled muscle movements drug-induced movement disorder
  • Stomach and intestinal disorders
    Symptoms: vomiting nausea
  • Liver disorders
    Symptoms: increased in alkaline phosphatase level increased bilirubin level
  • Endocrine disorders
    Symptoms: increased blood sugar level
  • Infectious disorders
    Symptoms: respiratory infections
  • Symptoms: anxiety insomnia
  • Musculoskeletal disorders
    Symptoms: joint pain
  • Heart rhythm problems
    Tell the doctor right away if you faint or have an irregular heartbeat.
Your doctor has prescribed Valbenazine Tosylate because they judge that the benefit is greater than the risk posed by side-effects. Many people using this medicine do not have serious side-effects. This page does not list all possible side-effects of Valbenazine Tosylate.
If you experience side-effects or notice other side-effects not listed above, contact your doctor for medical advice. You may also report side-effects to your local food and drug administration authority. You can look up the drug authority contact information from the Drug Authority Finder at TabletWise.com.

Side-effects and Allergic Reactions of Valbenazine by Severity and Frequency

Common Side-effects

Following are the common side-effects of this medicine:

Infrequent and Rare Side-effects

Following are the infrequent and rare side-effects of this medicine:

Severe Side-effects

Following are the severe side-effects of this medicine:
  • anxiety
  • arthralgia
  • disturbance in attention
  • drooling
  • dyskinesia
  • extrapyramidal symptoms
  • increase in alkaline phosphatase level
  • increased bilirubin level
  • increased blood glucose
  • insomnia
  • respiratory infections
  • urinary retention
  • vomiting
If you experience side-effects or notice other side-effects not listed above, contact your doctor for medical advice. You may also report side-effects to your local food and drug administration authority. You can look up the drug authority contact information from the Drug Authority Finder at TabletWise.com.

Warnings

Excessive Sleepiness

Valbenazine can cause excessive sleepiness. Activities demanding mental awareness which includes operating hazardous machinery or a motor vehicle should not be performed by these patients. Patients should avoid such activities untill they know how Valbenazine will affect them.

Heart Disorders

Patients those who are taking strong CYP3A4 or CYP2D6 inhibitor, or those who are CYP2D6 weak metabolizers are at an increased risk while using this medicine. Valbenazine may increase heart rhythm disorder. Valbenazine should not be used in patients with heart disorders related to heart rhythm disorders. Patients with a high risk of heart rhythm disorders, estimate the QT interval before increasing the dosage. Patients who are at increased risk need dose reduction. Reduce the dose to 40 mg once daily in patients who are on strong CYP3A4 inhibitor.

Interactions with Valbenazine

When two or more medicines are taken together, it can change how the medicines work and increase the risk of side-effects. In medical terms, this is called as a Drug Interaction.
This page does not contain all the possible interactions of Valbenazine Tosylate. Share a list of all medicines that you use with your doctor and pharmacist. Do not start, stop, or change the dose of any medicines without the approval of your doctor.

Strong CYP2D6 Inhibitors

Valbenazine Tosylate interacts with strong CYP2D6 inhibitors (paroxetine and fluoxetine) which are used to treat depression or panic disorders and (quinidine) which is used to treat heart disease. The combined use of Valbenazine with strong CYP2D6 inhibitors increase the absorption of valbenazine and its active metabolites as compared to the use of Valbenazine alone. It may increase the risk of exposure-related side effects including heart rhythm disorder. The dose of Valbenazine should be reduced on the basis of tolerability when used in combination with strong CYP2D6 inhibitors.

Strong CYP3A4 Inhibitors

There may be an interaction of Valbenazine with strong CYP3A4 inhibitors (itraconazole and ketoconazole which are used to treat a number of fungal infections and clarithromycin which is used to treat various bacterial infections). The combined use of Valbenazine with strong CYP3A4 inhibitors increase the absorption of valbenazine and its active metabolites as compared to the use of Valbenazine alone. It may increase the risk of exposure-related side effects including heart rhythm disorder. The dose of Valbenazine should be reduced when used in combination with strong CYP3A4 inhibitors.

Monoamine Oxidase Inhibitors

Valbenazine Tosylate may interact with monoamine oxidase inhibitors (isocarboxazid, phenelzine, selegiline) which are used to treat mental disorder. The combined use of Valbenazine with monoamine oxidase inhibitors may increase the level of monoamine neurotransmitters in the space between two nerve cells. It leads to an increase in the risk of side effects such as abnormally high level of serotonin and Valbenazine effect get reduced. It is advised to avoid combined use of Valbenazine and monoamine oxidase inhibitors.

Digitalis Glycosides

Your doctor's guidelines may need to be followed while taking this medicine along with digitalis glycosides (digoxin) which are used to treat various heart conditions. The combined use of digoxin with Valbenazine increase the level of digoxin due to the reduction of intestinal P-glycoprotein. The level of digoxin should be monitored when digoxin is used with Valbenazine. Risk of increased side effects is related to increased exposure to digoxin. Therefore digoxin dose adjustment is required.

Strong CYP3A4 Inducers

Special instructions need to be followed while taking this medicine along with strong CYP3A4 inducers. The combined use of Valbenazine with strong CYP3A4 inducers decreased the absorption of valbenazine and its active metabolites as compared to the use of Valbenazine alone. It may reduce the effectiveness of Valbenazine. The combined use of Valbenazine with strong CYP3A4 inducers should not be recommended.

Interactions of Valbenazine by Severity

Serious

The following medicines may interact when taken together and can cause harmful effects in the body. Please consult with your doctor or pharmacist before taking these medicines together.

Moderate

The following medicines may interact when taken together and can increase your risk of harmful effects. Please consult with your doctor or pharmacist before taking these medicines together.

When should Valbenazine be not used?

Traveling With Medication

  • Ensure that you carry enough doses of each of your prescription medicines to last the entire trip. The best place to store your medicines is in the carry on baggage. However, while flying, if carrying liquid medicines, make sure you do not go over the limits imposed for carry-on liquids.
  • While traveling overseas, make sure that you can carry each of your prescription medicines legally to your destination country. One way to ensure this is by checking with your destination country's embassy or website.
  • Make sure that you carry each of your medicines in their original packaging, which should typically include your name and address, and the details of the prescribing doctor.
  • If your travel involves crossing time zones, and you are required to take your medicine as per a fixed schedule, make sure that you adjust for the change in time.

Expired Medication

Taking a single dose of expired Valbenazine is unlikely to cause a side-effect. However, please discuss with your doctor or pharmacist, if you feel unwell or sick. An expired medicine may become ineffective in treating your prescribed conditions. To be on the safe side, it is important not to use an expired drug. You are much safer by always keeping a fresh supply of unexpired medicines.

Safe Disposal of Medication

  • If there are disposal instructions on the package, please follow the instructions.
  • If there are medicine take-back programs in your country, you should contact the respective authority to arrange for the disposal of the medicine. For example, in the USA, the Drug Enforcement Administration regularly hosts National Prescription Drug Take-Back events.
  • If there are no take-back programs, mix the medicine with dirt and place them in a sealed plastic bag. Throw the plastic bag in your household trash. Separately, remove all personal information including the prescription label from the medicine packaging and then dispose off the container.
  • If specifically indicated on the medicine package that it needs to be flushed down the toilet when no longer needed, perform the required step.
This page provides information for Valbenazine Tosylate .
Tardive Dyskinesia
Brain Diseases
Neurologic Diseases
Movement Disorders

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